From Start to Finish: Your Clinical Research Partner
GCP Training and Courses
I offer GCP (Good Clinical Practice) training and courses tailored to various audiences, including:
Students: Foundational GCP courses designed to introduce students to the essential principles and requirements of clinical research.
Medical Teams: In-depth training for healthcare professionals involved in clinical trials, focusing on their roles in ensuring compliance with GCP.
Research Coordinators: Targeted courses that provide coordinators with the knowledge and skills necessary to manage clinical trials in accordance with GCP standards.
Delivery: Courses can be delivered in-person or online, based on your needs, ensuring flexible and effective learning.
Audits and Compliance
I provide professional auditing services to ensure that clinical trials meet the highest standards of quality and compliance. My audit services include:
Site Audits: Conducting thorough reviews of clinical trial sites to assess their compliance with GCP, FDA, and other regulatory requirements.
Process Audits: Reviewing trial processes to identify any gaps or inefficiencies that may compromise data integrity or patient safety.
Regulatory Audits: Ensuring that all trial activities align with regulatory standards and preparing sites for inspections by regulatory authorities.
Audit Reports and Follow-ups: Providing detailed audit reports with actionable recommendations for corrective actions and improvements, followed by re-audits if necessary.
SOP Development and Review
I offer specialized services in Standard Operating Procedures (SOPs) for clinical trials, ensuring that processes are efficient and compliant:
SOP Review: Assessing existing SOPs to ensure they align with current GCP standards, regulatory guidelines, and industry best practices.
SOP Drafting: Crafting new SOPs tailored to the specific needs of clinical trial sites and teams, ensuring clarity, efficiency, and compliance.
Clinical Studies Ethical Consultancy
With extensive expertise in clinical research ethics, I offer tailored consultancy services to ensure your trials meet the highest ethical standards. My services include:
Ethical Risk Assessment: Evaluating study designs and protocols to identify potential ethical concerns and recommend actionable solutions to address them.
Regulatory Alignment: Ensuring adherence to local and international ethical guidelines, including FDA, EMA, and GCP standards, while respecting cultural and regional considerations.
Informed Consent Support: Developing clear and comprehensive consent processes that prioritize participant understanding and autonomy, ensuring compliance with ethical principles.
Participant Rights and Safety: Providing strategies to safeguard participant rights, minimize risks, and uphold the principles of justice, beneficence, and respect.
Ethical Training and Education: Offering workshops and training programs to equip your team with the knowledge to navigate ethical challenges in clinical research.
Ethics Committee Liaison: Facilitating communication and submissions to Institutional Review Boards (IRBs) or Ethics Committees, ensuring smooth approval processes.
Clinical Research Associate (CRA) Services
As a highly experienced Lead Clinical Research Associate (CRA), I provide comprehensive support for clinical trials across all phases. My services include:
Site Selection and Setup: Evaluating clinical trial sites to ensure they meet the requirements for conducting high-quality studies. Overseeing the setup and preparation of trial sites, including necessary materials and training.
Trial Monitoring and Oversight: Managing clinical trials to ensure adherence to Good Clinical Practice (GCP), FDA guidelines, and study protocols. Regular on-site and remote monitoring to assess trial progress and data accuracy.
Data Management and Reporting: Ensuring the timely and accurate collection of trial data, providing detailed reports, and maintaining compliance with regulatory standards.
Subject Recruitment and Consent: Facilitating the recruitment of eligible subjects for trials and ensuring that informed consent is obtained in accordance with ethical and regulatory requirements.
Regulatory Compliance: Liaising with regulatory authorities and ensuring that all study activities comply with relevant laws and guidelines.
